In fields such as clinical medicine, forensic sciences, environmental quality testing, food quality assurance, drug testing, and other areas, it has become possible to determine the presence and/or amount of trace substances in test samples even when such substances are present in very low concentrations (on the order of parts per million, or even billion). For example, in clinical testing, medical procedures, the consequences of which even if favorable can alter family life, rest on veracity of identification and non-adulteration of a test specimen. Substance abuse has given rise to widespread urine specimen testing. Positive test results identifying an illicit substance in a specimen may have a profound impact on the donor's career or employment. In the proper circumstances, positive test results may also result in criminal liability for the donor. As another example, the U.S. Environmental Protection Agency conducts a variety of ongoing testing programs. These testing programs are intended to guarantee compliance with standards for maximum levels of toxic and/or radioactively contaminated fluids, such as plant effluent, and results of tests can figure in civil and criminal liabities.
The familial, societal and juridical consequences which ride on the trustworthiness of test results and absolute linkage of test results to the specimen actually collected dictate the need for methods and apparatus that provide:
(1) honest specimens; PA1 (2) specimen collection containers that are PA1 (3) operations for obtaining multiple aliquots from specimen containers which PA1 (4) custody and identification tracing procedures that assure certainty of specimen identity ("chain of custody") during every phase of PA1 (5) safeguards from dishonest intervention for the purpose of defeating honest testing operations.
(a) tamper proof, and PA2 (b) capable of providing PA2 (a) eliminate potential sources for adulteration of the specimen from which the aliquot is taken, and PA2 (b) eliminate potential sources of adulteration of the aliquot taken from the specimen container; PA2 (a) specimen collection, then PA2 (b) obtaining aliquots from specimen containers, then PA2 (c) the sequences of PA2 (d) storage of specimen at the testing facility,
(i) multiple sampling from the specimen container to obtain aliquots of PA4 (x) a first sample on which to conduct a screening test, and PA4 (y) a subsequent sample, if the first sample screens positive, on which to conduct rigorous verification testing, and PA3 (ii) a redundant previously unsampled original specimen for third party confirmation testing of results obtained in the screening and verification tests; PA3 (i) screening tests, then PA3 (ii) subsequent verification testing of positive screens, and then PA3 (iii) third party testing to confirm positive analyses of screen positives, and
Particularly in the area of testing for substance abuse, large and increasingly high volumes of urine testing has created a need for specialized specimen collection containers and automated handling of specimen collection containers.
Thus, there has been a need for a liquid specimen collection containers that provide for more than one isolated specimen of a sample to provide redundancy for third party confirmation testing, that automatically retains an archival specimen so that tests may be repeated on the identical specimen and the results of the screening tests either verified or disproved, and that cannot be accessed without evident tamper. Providing these benefits, a specimen collection container device has been invented which eliminates human contact with the specimen once the specimen is sealed in the device, and which provides split specimen collection. This device is described in pending U.S. Patent application Ser. No. 08/027,860, filed Mar. 8, 1993, now abandoned, and entitled "Fluid Sample Receptacle", and also described briefly herein.
A need exists for automated sampling to obtain aliquots from of specimen collection devices that have certain features of devices described in U.S. Patent application Ser. No. 08/027,860 and herein. The aliquots are used for the screening and verification tests. Automated sampling must, however, assure or contribute to the assurance of the objectives set forth above for operations for obtaining multiple aliquots from specimen containers, for custody and identification tracing procedures that assure certainty of specimen identity ("chain of custody") during operations for obtaining aliquots from specimen containers and linkage to specimen storage, and for safeguards from dishonest intervention for the purpose of defeating honest testing operations.